PUCCINI Interim Reports – 2014

Update May 2014

Rationale:

Surgery is common in both Crohn’s disease (CD) and ulcerative colitis (UC). There is controversy within the literature as to what the risk factors are for post-operative complications in IBD patients. One of the central questions for which the current literature is heterogeneous is whether use of anti-TNF agents peri-operatively poses a risk for infectious and non-infectious complications. The treatment paradigm for both CD and UC has shifted towards early control of disease with immunosuppressive agents, particularly anti-TNF agents. If anti-TNF agents are found to pose a risk for post-operative complications the management of IBD patients in the peri-operative period would need to be changed.

Hypothesis:

The primary hypothesis is that peri-operative anti-TNF exposure is an independent risk factor for 30 day incidence of post-operative infection in intra-abdominal surgery for CD and UC

Aims:

Aim 1: Determine whether exposure to anti-TNF agents is an independent risk factor for post-operative infection in intra-abdominal surgery for CD and UC

Explore use of peri-operative anti-TNF drug levels as a measure of risk for post-operative infection

Aim 2: Determine whether exposure to anti-TNF agents is an independent risk factor for important non-infectious post-operative outcomes in intra-abdominal surgery for CD and UC such as ileus/small bowel obstruction, thromboembolic event, reoperation, and mortality

Explore use of peri-operative anti-TNF drug levels as a measure of risk for non-infectious post-operative outcomes

Contract agreement was reached with Prometheus Labs to provide anti-TNF level analysis free for the study.

Sub-site agreements are currently being finalized with the individual sites. Participating centers include: Boston University Medical Center, Brigham and Women’s Hospital, Carle Foundation Hospital, Cedars-Sinai Hospital, Cleveland Clinic Foundation, Dartmouth-Hitchcock Medical Center, Lenox Hill Hospital, Massachussetts General Hospital, Mayo Clinic Arizona, Mayo Clinic Rochester, the Mount Sinai Hospital, Penn State Hershey, University of Chicago, University of California San Francisco, University Hospitals Case Medical Center, University of Colorado, University of Florida, University of Maryland, University of Michigan Hospital, University of North Carolina Hospitals, University of Pennsylvania, University of Pittsburgh, and Wake Forest University.

Sites will be paid $250j per patient enrolled with an enrollment cap of 150 patients for any one center.

Site initiation meeting will be planned for DDW in May at which time investigators can be oriented for the beginning of enrollment.

Sites will be expected to participate in 2 conference calls per month during the patient enrollment phase.